Question 1

Employees working in the controlled environment should be properly trained on ___________.

Options :

A : Gowning procedures

B : Requirements for attire and behavior

C : Gowning procedures, requirements for attire and behavior

D : Gowning procedures and requirements for attire

Answer: C

Question 2

The term or period during which a commodity remains suitable for the intended use is called ________.

Options :

A : Intended use period

B : Usage life

C : Suitable life

D : Shelf life

Answer: D

Question 3

What can be the best suitable ‘severity’ rating to measure the possible consequences of hazard if the hazard can result in ‘patient death’? NOTE: Rating scale from highest to lowest: catastrophic, critical, serious, minor & negligible.

Options :

A : Serious

B : Minor

C : Catastrophic

D : Negligible

Answer: C

Question 4

If validation study was not conducted on resterilization, what is true?

Options :

A : The device can be resterilized and the same is recorded in Design master record

B : The device can be resterilized and the same is recorded in Device history record (DHR)

C : The device cannot be resterilized

D : The device can be resterilized and the same is recorded on product label

Answer: C

Question 5

According to ISO 19011:2018, Determining auditor competence should consider __________.

Options :

A : Personal behaviour

B : Generic knowledge and skills

C : Discipline and sector-specific competence

D : Personal behaviour, Generic knowledge and skills, and Discipline and sector-specific competence

Answer: D